If you have seen Marathon Man (the film) you will know the scene of "Is it safe". So on the way to emergeny dentist this morning it sprang to mind.
Cladribine failed with the regulators based on safety issues
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MS Drug Cladribine
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PML Natalizumab :1:50-100 Not reported
Fingolimod Yes
Tecfidera Yes
anti-CD20 Yes
Secondary Autoimmunities Alemtuzumab 50% Not Reported
HSCT 10%
Grade 3/4 Lymphopaenia Alemtuzumab >95% 25%
Malignancies in Trials Ocrelizumab 8 verses 0 3 verses 0
(verse placebo) Not different compared to other DMT
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Given their recent track records of approvals, would the regulators be accused of bias if they continue to reject access
CoI: None. ProfG PI on CLARITY study.
Labels: Cladribine4MS